Oznaczanie CA125 po I linii Pro i kontra. Krzysztof Sodowski vs Radosław Mądry Klinika Onkologii Uniwersytetu Medycznego w Poznaniu

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1 Oznaczanie CA125 po I linii Pro i kontra Krzysztof Sodowski vs Radosław Mądry Klinika Onkologii Uniwersytetu Medycznego w Poznaniu

Early treatment of relapsed ovarian cancer based on

conventional clinical indicators Results of the

Rustin (Mount Vernon Cancer Centre) and Maria van der

3 Early treatment of relapsed ovarian cancer based on CA125 level alone versus delayed treatment based on conventional clinical indicators Results of the randomized MRC OV05 and EORTC trials Gordon Rustin (Mount Vernon Cancer Centre) and Maria van der Burg On behalf of all OV05 and Collaborators 31 st May 2009

4 Ovarian Cancer Most of these patients will benefit from further therapy Serial measurement of circulating tumour markers have the potential for earlier detection of relapse It is unclear whether patients benefit from earlier treatment of relapse Objective of Trial To investigate the benefit of early chemotherapy for relapsed ovarian cancer, based on a raised CA125 level alone, versus delayed chemotherapy based on conventional clinical indicators

5 Trial Profile 36,6%

6 Randomisation Affecting Events 29% 36,6% 15% 4% 4% 9%

7 Second-line chemotherapy Regimen administered Single agent platinum Combination platinum (no taxane) Platinum and taxane based Taxane without platinum Other Unknown treatment No treatment given Not yet given (no clinical relapse) Early N= (29%) 40 (15%) 91 (34%) 15 (6%) 28 (11%) 2 (1%) 11 (4%) 0 Delayed N= (25%) 34 (13%) 102 (38%) 9 (3%) 15 (6%) 6 (3%) 24 (9%) 7 (3%) Secondary surgery 21 (8%) 14 (5%)

8 Proportion alive not started second-line chemotherapy Time from randomisation to second-line chemotherapy Median (months) Early 0.8 Delayed 5.6 HR=0.29 (95% CI 0.24, 0.35) p< % Months since randomisation Number at risk Early Delayed

9 Outcomes (data frozen 16 th February 2009) N=529 Alive Dead Cause of death: Disease related Chemotherapy related Disease & Chemotherapy related Other Missing 159 (30%) 370 (70%) Median follow-up (months) 56.9

10 Proportion surviving Overall Survival Number at risk Early Delayed HR=0.98 (95%CI=0.80, 1.20), p= Months since randomisation Median months (95%CI) Early 25.7 (23.0, 27.9) Delayed 27.1 (22.8, 30.9)

11 Proportion alive without deterioration in GHS Time from randomisation to first deterioration in Global Health Score (or death) Number at risk Early Delayed Months since randomisation Median (months) Early 3.2 Delayed 5.8 HR=0.71 (95% CI 0.58, 0.88) p=

12 Conclusions In early treatment arm based on rise in CA125 Second-line chemotherapy started a median of 4.8 months earlier Third-line chemotherapy started a median of 4.6 months earlier This early treatment did not improve overall survival HR=0.98; 95%CI=0.80, 1.20; p=0.85 Absolute difference at 2 years 0.7% (95%CI -7.6, 4.5%) Early chemotherapy does not improve Qol

13 How should this trial influence practice? Women can be reassured that There is no benefit from early detection of relapse by routine CA125 measurements Even if CA125 rises, chemotherapy can be delayed until signs or symptoms of tumor recurrence Women can be offered informed choices in follow-up No routine CA125 measurements but rapid access to CA125 testing if symptoms or signs of relapse Regular CA125 measurements

14 Gordon Rustin Correct meaning of cure To get rid of: elimanate; eradicate; heal; restore to normal health; very different from remission Właściwe znaczenie wyleczyć - wyeliminować; - pozbyć się; - wykorzenienia; - przywrócić do normalnego stanu zdrowia; bardzo różni się od pojęcia remisja

16 Rozpoczęcie chemioterapii jedynie na podstawie wzrostu CA125 nie wydłuża czasu przeżycia To po co oznaczać CA125 po I linii?

Częstość wznów po leczeniu I rzutu Miesiące % W czasie chemii 5,3 0-6 17,2 0-12

17 Częstość wznów po leczeniu I rzutu Miesiące % W czasie chemii 5, , , , ,7 bez wznowy 17,7 Razem 100,0 du Bois A. et al. Cancer 2009

18 Cel leczenia wznowy Wydłużenie czasu przeżycia Opóźnienie progresji Kontrola objawów choroby Zmniejszanie objawów związanych z leczeniem Utrzymanie lub poprawa jakości życia

19 Czy wczesna cytoredukcja poprawia wyniki leczenia? Wyniki leczenia poprawia doszczętna nie wczesna cytoreducja

Potwierdzają to liczne badania ale tylko retrospektywne Harter P Surgery in Recurrent Ovarian Cancer: The Arbeitsgemeinschaft Gynaekologische Onkologie (AGO) DESKTOP OVAR Trial Annals of Surgical

20 Potwierdzają to liczne badania ale tylko retrospektywne Harter P Surgery in Recurrent Ovarian Cancer: The Arbeitsgemeinschaft Gynaekologische Onkologie (AGO) DESKTOP OVAR Trial Annals of Surgical Oncology, 2006, 13(12): <1 cm 85% 45 months 19 months < Oksefjell H, Sandstad B, Trope C. The role of secondary cytoreduction in the management of the first relapse in epithelial ovarian cancer. Ann Oncol. 2009;20: >2 cm /<2 cm/0 cm 31% 54 months 27.6 months 8.4 months 0.01

21 AGO score good performance status Eastern Cooperative Oncology Group 0), complete resection at primary surgery (or alternatively, International Federation of Gynecology and Obstetrics stage I/II) absence of ascites.

22 A retrospective population-based study: 789 patients treated for their initial recurrence ( ) 217 had SCR and 572 were treated with chemotherapy alone. SCR (second cytoreduction ) was chosen for 217 (27%). After SCR without macroscopic tumour 68 (35%) /31%/ 9% tumour nodules <2 cm 33 (17%) /15%/ 4% tumour nodules >2 cm 95 (48%) /44%/ 12% wykluczono z analizy wielkości resztek 21 /10%/ 3% Residual disease after SCR, treatment-free interval (TFI) and age were found to be prognostic factors for overall survival (OS) in multivariate analysis. Localised tumour was found to be the only significant factor to predict complete optimal cytoreduction (COC).

23 Survival wielkość resztek 0cm = 4.5 <2 cm 2.3 >2 cm 0.7 (years) p < Oksefjell H et al. Ann Oncol. 2009

24 Survival typ leczenia localised disease 3.4 disseminated disease 1.0 only chemotherapy 1.1 (years) p< 0.01 Oksefjell H et al. Ann Oncol. 2009

Survival czas wolny od choroby 24 months 4.5 12 23 months 1.

25 Survival czas wolny od choroby 24 months months 1.6 <12 months 0.8 (years) p< 0.01 Oksefjell H et al. Ann Oncol. 2009

26 Guidelines Oksefjell H et al. Ann Oncol. 2009

27 Tak o ile będzie można przeprowadzić cytoredukcję do 0 Czy oznaczanie CA125 może być czynnikiem predykcyjnym przeprowadzenia cytoredukcji do 0? TAK

32 Musimy poczekać na prospektywne badania DESKTOP III GOG 213

33 AGO-OVAR DESKTOP III (Protocol AGO - OVAR OP.4) A randomized trial evaluating cytoreductive surgery in patients with platinum-sensitive recurrent ovarian cancer Complete resection seems feasible and a positive AGO-score Strata: Platinum-free-interval 6-12 vs > 12 months - 1st line platinum based chx: yes vs no R A N D O M Cytoreductive surgery no surgery platinum-based chemotherapy* recommended * Recommended platinum-based chemotherapy regimens: - carboplatin/paclitaxel - carboplatin/gemcitabine - carboplatin/pegliposomal doxorubicin (if calypso-trial shows equivalence to carboplatin-paclitaxel) -or other platinum combinations in prospective trials

34 Secondary Cytoreductive Surgery and Bev in Recurrent Disease GOG 213 ongoing Women with recurrent ovarian, peritoneal primary or fallopian tube cancer and a TFI 6 months Surgical candidate Yes No Surgery No Surgery R A N D O M I Z E Carboplatin AUC 5 + Paclitaxel 175 mg/m 2 every 21 days Carboplatin AUC 5 + Paclitaxel 175 mg/m 2 + Bevacizumab 15 mg/kg every 21 days Bevacizumab 15 mg/kg every 21 days until progression or toxicity precludes further treatment GOG Statistical Report, July 2008.

35 I jeszcze raz Gordon Rustin Our findings showed no evidence of a survival benefit with early treatment of relapse on the basis of a raised CA125 concentration alone, and therefore the value of routine measurement of CA125 in the followup of patients with ovarian cancer who attain a complete response after first-line treatment is not proven. "Nasze wyniki nie wykazały poprawę przeżycia przy wczesnym leczeniu nawrotu choroby w oparciu jedynie o wzrost stężenia CA125, zatem wartość rutynowych pomiarów CA125 w trakcie nadzoru u pacjentek z rakiem jajnika, które osiągnęły całkowitą odpowiedź po I linii leczenie nie jest udowodnione.

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